The present disclosure relates to cartilage repair compositions and methods for modifying the proteoglycan content of the compositions. Specifically, the methods relate to serum free, collagen free neocartilage made from chondrocytes that can be used for implants. Proteoglycans, such as aggrecan and sulfated glycosaminoglycan are used and the content modified using temperature changes.

Implants for repairing tissue defects, such as cartilage tissue defects, and methods of their preparation and use are disclosed. A mold of a tissue defect is prepared by pressing upon the defect a substrate having shape memory, such as aluminum foil. The mold, which has contours substantially conforming to those of the defect, is removed from the defect, and tissue particles are added to the mold ex vivo. A biological carrier such as biocompatible glue is also added to the mold. The combination of tissue particles and the biological carrier thereby form an implant, which retains its shape after separation from the mold. The implant can be transferred to the tissue defect, with contours of the mold matching corresponding contours of the defect.

The present application discloses compositions, methods and devices for treatment of a degenerative intervertebral disc. A composition can comprise chondrocytes expressing type II collagen. These chondrocytes can be obtained from human cadavers up to about two weeks following death, and can be grown in vitro. The compositions can further comprise one or more biocompatible molecules. Treatment of a degenerative disc can comprise injecting or implanting a composition comprising the chondrocytes into a degenerative disc through an aperture or incision. If the aperture or incision is closed with a suture or a glue after introduction of the chondrocytes, the closure can withstand over 400 N of compression force.

A synthetic, flexible tissue matrix and methods for repairing hyaline cartilage defects in a joint using the flexible tissue matrix are described. The flexible tissue matrix includes a high molecular weight polycaprolactone polymer entangled with a polysaccharide such as hyaluronic acid. In the methods, autologous bone mesenchymal stem cells are introduced to a joint by a microfracturing technique, and a membrane made of the flexible matrix is applied to the joint. Cartilage which forms in the joint is hyaline cartilage rather than fibrocartilage.

Compositions and methods for repair of tissue defects are disclosed. The compositions are prepared by entangling high molecular weight polycaprolactone polymer molecules with a polysaccharide such as hyaluronic acid by a dual solvent emulsion process to produce a porous flexible matrix which supports cell and tissue growth in vivo and ex vivo.

The present disclosure describes an injection pressure monitoring device including a pressure sensor, an injection pressure monitoring system and kits for monitoring injection pressure generated at a needle tip when injecting a therapeutic fluid composition into tissue, to avoid generating potentially damaging pressure in the tissue being treated.

DESCRIPTION provided by applicant The goal of this project is to provide a synthetic biomaterial capable of giving long term repair of full thickness chondral lesions with the aim of helping to reduce the joint replacements carried out each year in the USA Our company has developed a synthetic biomaterial technology with proven biocompatibility in treating over patients for bone repair This highly biocompatible technology is designed to provide an in situ organized environment for the regeneration of new tissue and has recently been shown to provide excellent repair in a pre clinical osteochondral model In this study the regenerate tissue not only repaired the subchondral bone but also produced well integrated hyaline cartilage and re established the tide mark zone Building on the preliminary results from the pre clinical osteochondral study and our patent protected position on the materialandapos s use with microfracture Phase I of this proposal seeks initially to establish proper surgical method for implantation of the biomaterial in lesions with sizes spanning those normally treated by microfracture to cm An ovine model is chosen to conform to preferences expressed by the FDA Having established proper fixation technique in Phase I the Phase II of the proposal derives data for use in a pre clinical safety and efficacy study Data from this accepted ovine model will form the basis of approach to the FDA to obtain an investigational device exemption IDE necessary to enter human clinical trials to support Pre Market Authorization PMA for the commercial product This treatment modality represents a safe cost effective long term solution to an increasing patient population PUBLIC HEALTH RELEVANCE Cartilage lesions are known to often progress to osteoarthritis which is the leading cause of disability among U S adults affecting an estimated million individuals at a cost of more than $ billion per year in health care expenses and lost productivity An estimated million arthroscopies are performed annually with approximately involving microfracture procedures The research presented in this proposal aims to solve the major deficiency in first line surgical repair of chondral defects by providing a means of regenerating hyaline cartilage using a synthetic biocompatible and fully resorbable implant

DESCRIPTION provided by applicant The goal of this project is to provide a synthetic biomaterial capable of giving long term repair of full thickness chondral lesions with the aim of helping to reduce the joint replacements carried out each year in the USA Our company has developed a synthetic biomaterial technology with proven biocompatibility in treating over patients for bone repair This highly biocompatible technology is designed to provide an in situ organized environment for the regeneration of new tissue and has recently been shown to provide excellent repair in a pre clinical osteochondral model In this study the regenerate tissue not only repaired the subchondral bone but also produced well integrated hyaline cartilage and re established the tide mark zone Building on the preliminary results from the pre clinical osteochondral study and our patent protected position on the materialandapos s use with microfracture Phase I of this proposal seeks initially to establish proper surgical method for implantation of the biomaterial in lesions with sizes spanning those normally treated by microfracture to cm An ovine model is chosen to conform to preferences expressed by the FDA Having established proper fixation technique in Phase I the Phase II of the proposal derives data for use in a pre clinical safety and efficacy study Data from this accepted ovine model will form the basis of approach to the FDA to obtain an investigational device exemption IDE necessary to enter human clinical trials to support Pre Market Authorization PMA for the commercial product This treatment modality represents a safe cost effective long term solution to an increasing patient population
PUBLIC HEALTH RELEVANCE Cartilage lesions are known to often progress to osteoarthritis which is the leading cause of disability among U S adults affecting an estimated million individuals at a cost of more than $ billion per year in health care expenses and lost productivity An estimated million arthroscopies are performed annually with approximately involving microfracture procedures The research presented in this proposal aims to solve the major deficiency in first line surgical repair of chondral defects by providing a means of regenerating hyaline cartilage using a synthetic biocompatible and fully resorbable implant

The present disclosure provides a delivery device for delivering a tissue repair composition in paste form, such as a bone graft extender and substitute in paste form, for use in surgical procedures including minimally invasive spine (fusion) surgery, open spine surgery and other orthopedic procedures.

The present application discloses compositions, methods and devices for treatment of a degenerative intervertebral disc. A composition can comprise chondrocytes expressing type II collagen. These chondrocytes can be obtained from human cadavers up to about two weeks following death, and can be grown in vitro. The compositions can further comprise one or more biocompatible molecules. Treatment of a degenerative disc can comprise injecting or implanting a composition comprising the chondrocytes into a degenerative disc through an aperture or incision. If the aperture or incision is closed with a suture or a glue after introduction of the chondrocytes, the closure can withstand over 400 N of compression force.